Quality Associate III

Summary

As a Quality Associate III, you will own and manage assigned Quality Management System (QMS) processes supporting U.S. depot operations. Based in Skaneateles Falls, New York, this position serves as the primary Quality partner for U.S. depot operations and is accountable for process performance, compliance, risk identification, standardization, and continuous improvement. The role partners with Canadian depot operations to promote consistent execution of depot quality processes and alignment of Quality System requirements across UCAN. Independently evaluates complex quality and operational issues, applies critical thinking and risk-based decision-making, and drives practical, sustainable solutions. Partners with Service Operations and Global Service Quality to ensure depot processes comply with applicable regulatory requirements, Baxter policies, and approved procedures.

Essential Duties and Responsibilities

• Own and manage assigned Technical Services Quality Management System processes, including process requirements, controls, documentation, performance measures, governance, and continuous improvement.
• Serve as the primary Quality representative and subject matter expert for U.S. depot operations while partnering with Canadian depot operations to promote consistency and alignment across UCAN.
• Own assigned Quality Management System processes supporting U.S. depot operations. Provide oversight of depot service processes across U.S. depot locations and drive standardization, consistency, and alignment of Quality System requirements across UCAN depot operations.
• Evaluate depot service documentation, process controls, equipment and calibration controls, validations, material controls, and adherence to approved service procedures.
• Independently identify, analyze, and resolve complex quality and compliance issues using critical thinking, structured problem-solving, root-cause analysis, and risk-based decision-making.
• Lead or provide Quality approval for investigations, nonconformances, CAPAs, effectiveness checks, change controls, risk assessments, validations, and other quality records within delegated authority.
• Plan and conduct risk-based depot assessments; identify systemic gaps, establish improvement priorities, monitor effectiveness, and drive sustainable corrective actions across depot operations.
• Lead audit and inspection readiness activities, monitor quality metrics and trends, communicate risks and improvement plans through Management Review and leadership forums, and drive continuous improvement initiatives that support consistency and standardization across UCAN depot operations.

Qualifications

• Strong critical-thinking, analytical, and problem-solving skills with the ability to independently evaluate complex or ambiguous situations.
• Demonstrated ability to own and manage quality-system processes and drive measurable, sustainable improvement.
• Sound judgment and demonstrated ability to make risk-based quality decisions within delegated authority.
• Strong knowledge of medical device quality-system requirements, including applicable FDA requirements, ISO 13485, Good Manufacturing Practices, Good Documentation Practices, and data integrity principles.
• Experience with investigations, root-cause analysis, CAPA, change control, risk management, audits, validation, procedure development, training controls, and quality metrics.
• Proven ability to influence cross-functional stakeholders, constructively challenge ineffective practices, and drive accountability without direct authority.
• Strong technical-writing, communication, project-management, and organizational skills.
• Ability to manage multiple priorities and work independently across a matrixed organization supporting multiple depot locations.
• Ability to communicate effectively with depot personnel, process owners, functional leaders, senior management, auditors, and inspectors.
• Ability to travel to U.S. depot locations and, as needed, support activities that promote consistency and alignment across UCAN depot operations.

Education and/or Experience

• Bachelor's degree in engineering, science, or a related technical discipline required.
• Five or more years of experience in Quality, Service, Manufacturing, Engineering, or another regulated environment.
• Medical device industry experience strongly preferred.
• Demonstrated experience managing quality-system processes and leading cross-functional quality or process-improvement initiatives.
• Experience supporting depot, repair, refurbishment, service-center, distribution, or manufacturing operations preferred.
• Experience conducting audits, assessments, investigations, CAPA activities, and quality-system improvements in a regulated environment.
• Internal Auditor, ASQ, Lean, Six Sigma, or comparable quality certification preferred.

Additional Role Requirements

• Primary work location: Skaneateles Falls, New York.
• Travel to U.S. depot locations and, as needed, support activities that promote consistency and alignment across UCAN depot operations. Recommended posting language: up to 25%.
• Hybrid or onsite expectations will follow the applicable Baxter workplace policy and operational requirements.
• No direct supervisory responsibilities. The role may provide work direction, technical guidance, training, and approval of work performed by others within delegated Quality authority.
• Adheres to all environmental, health, safety, data integrity, and Good Documentation Practice requirements. Performs other duties as assigned.